NCT02206594

Brief Summary

A pilot study designed to assess the feasibility of planned descemetorhexis for the treatment of Fuchs' corneal dystrophy.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Last Updated

August 21, 2015

Status Verified

July 1, 2014

Enrollment Period

1.6 years

First QC Date

April 18, 2014

Last Update Submit

August 20, 2015

Conditions

Fuchs' Corneal DystrophyCataract

Outcome Measures

Primary Outcomes (1)

  • Corneal clarity as assessed by slit lamp photography

    Assessed up to 1 year following descemetorhexis

Secondary Outcomes (1)

  • Resolution of edema as assessed by slit lamp photography

    Assessed up to 1 year following descemetorhexis

Other Outcomes (1)

  • Reconstitution of the endothelial cell layer as assessed by specular microscopy

    Assessed up to 1 year following descemetorhexis

Study Arms (1)

Descemetorhexis

EXPERIMENTAL
Procedure: Descemetorhexis

Interventions

DescemetorhexisPROCEDURE
Descemetorhexis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient \>18 years old
  • Willing and able to provide informed consent
  • Fuchs' corneal dystrophy diagnosed
  • Cataract present
  • Best corrected visual acuity ≤ 20/40
  • Candidate for current endothelial transplant procedure (DSAEK, DMEK)

You may not qualify if:

  • \<18 years old
  • Medically unstable patient
  • Monocular patient
  • Unwilling or unable to provide informed consent
  • Corneal dystrophy other than Fuchs'
  • Central corneal scar or central opacity not related to Fuchs'
  • Severe nonproliferative diabetic retinopathy or proliferative diabetic retinopathy
  • History of prior vitreoretinal surgery
  • Advanced or unstable glaucoma
  • Known steroid responders with glaucoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Fuchs' Endothelial DystrophyCataract

Condition Hierarchy (Ancestors)

Corneal Dystrophies, HereditaryCorneal DiseasesEye DiseasesEye Diseases, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLens Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Steven B. Koenig, MD

Study Record Dates

First Submitted

April 18, 2014

First Posted

August 1, 2014

Study Start

January 1, 2014

Primary Completion

August 1, 2015

Last Updated

August 21, 2015

Record last verified: 2014-07

Locations

US(1)